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Revolutionizing ALS Treatment: BrainStorm’s Phase 3b Trial Moves Forward with FDA Approval

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BrainStorm Cell Therapeutics Inc., a leader in adult stem cell therapeutics for neurodegenerative diseases, has achieved a significant milestone with the FDA’s agreement on a Special Protocol Assessment (SPA) for its Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).

This agreement marks a critical step in advancing the potential treatment to the market, offering hope to those battling this devastating condition.

Understanding the SPA and Its Impact on ALS Research

The SPA is a pivotal agreement with the FDA, confirming the clinical trial protocol and statistical analysis plan for NurOwn’s Phase 3b trial.

This validation is essential for the trial’s objectives, supporting a future Biologics License Application (BLA) in ALS. BrainStorm’s CEO, Chaim Lebovits, expressed optimism about the SPA’s role in de-risking regulatory aspects and moving closer to offering a new treatment for ALS patients.

What’s Next for NurOwn®?

The trial, set to commence in 2024, aims to enroll participants early in their ALS progression, focusing on efficacy and safety.

The study design includes a double-blind, placebo-controlled phase, followed by an open-label extension, ensuring comprehensive evaluation of NurOwn’s impact on ALS.

The Path Forward: A Beacon of Hope for ALS Patients

This advancement represents more than just a clinical milestone; it’s a beacon of hope for the ALS community.

With a robust trial design and a committed team, BrainStorm is poised to make significant strides in ALS treatment, potentially altering the disease’s landscape.

In conclusion, BrainStorm Cell Therapeutics’ agreement with the FDA under the SPA for the Phase 3b trial of NurOwn in ALS is a monumental step towards introducing a novel treatment. As the trial progresses, it will be crucial to monitor its outcomes and the potential impact on ALS treatment paradigms.

*** All content on is for informational purposes only. All medical questions and concerns should always be consulted with your licensed healthcare provider.

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